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FDA Drug Application 016273 by US PHARM HOLDINGS

Application Number016273
Application Type New Drug Application
Sponsor ApplicantUS PHARM HOLDINGS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP07/1/1966N       
AP03/20/1975SOA       
AP07/21/1976SLR       
AP01/10/1977SCE       
AP02/9/1977SCP       
AP04/24/1978SLR       
AP04/24/1978SCS       
AP04/24/1978SLR       
AP04/24/1978SLR       
AP02/5/1980SCP       
AP07/2/1979SLR       
AP03/27/1981SLR       
AP02/4/1981SCM       
AP06/2/1986SPD       
AP08/2/1982SCP       
AP03/15/1983SCP       
AP08/2/1983SCM       
AP09/14/1983SCE       
AP02/9/1987SCM       
AP03/8/1991SCS       
AP03/15/1990SPD       
AP010/23/1991SLR       
AP06/1/1992SCP       
AP04/6/1992SCP       
AP011/13/1992SLR       
AP01/26/1995SLR       
AP05/1/1995SCM       
AP06/24/1996SCM       
AP012/4/1997SCM       
AP010/8/1998SCP       
AP01/14/1999SCP       
AP02/8/2006SLR13659057   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/016273s057ltr.pdf 2/22/2006
AP010/22/2008SLR21050060   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/016273s060ltr.pdf 10/23/2008
AP010/18/2010SLR26690061   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/016273s061lbl.pdf 10/18/2010
AP010/18/2010SLR26716061   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/016273s061ltr.pdf 10/20/2010
AP03/27/2012SLR32244066   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/016273s066ltr.pdf 3/28/2012
AP03/27/2012SLR32268066   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/016273s066lbl.pdf 3/28/2012
AP03/4/2016SLR45392068   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/016273Orig1s068ltr.pdf 3/8/2016
AP03/4/2016SLR45393068   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016273s068lbl.pdf 3/8/2016




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